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Job Requirements of Senior Instrument Verification & Validation Engineer:
-
Employment Type:
Contractor
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Location:
Rochester, NY (Onsite)
Do you meet the requirements for this job?
Senior Instrument Verification & Validation Engineer
Careers Integrated Resources Inc
Rochester, NY (Onsite)
Contractor
Job Title : Senior Instrument Verification & Validation Engineer
Location : Rochester, NY
Duration : 12+ Month (High possibility of Extension)
Pay range: $63 - $70/hr. on W2
Job Responsibilities:
Work Environment:
Location : Rochester, NY
Duration : 12+ Month (High possibility of Extension)
Pay range: $63 - $70/hr. on W2
Job Responsibilities:
- Designing and implementing software of embedded devices and systems.
- Designing, developing, coding, testing, and debugging system software.
- Develop Requirements based manual test procedures.
- Access requirements for testability and determine best test approach.
- Compile and analyze test results.
- Document and manage system software defects.
- Participate in regular scheduling and team meetings.
- Participate in regular off hour meetings with partner in China.
- Understand project goals and timelines and provides support to ensure product launch success.
- Perform other work-related duties as assigned.
- Seeking a Verification and Validation SR Engineer to help with formal verification and validation of complex medical devices under the regulations of the FDA.
- The individual will be part of an engineering team that is responsible for requirements based manual test case design and execution of test procedures in a BL2 lab environment.
- The team is highly collaborative and will require regular interactions in formal reviews, test planning activities, and working with software development and partners to reproduce and verify system defects.
- The job is 100% onsite.
- Occasional travel required.
- The 20% travel includes airplane, automobile travel and overnight hotel.
- B.S. or M.S. Degree in Computer Science, Chemistry, Biochemistry, Biology, Engineering, or a related discipline required.
- 10+ years required, preferably in a medical device environment.
- Familiarity with software configuration management tools, defect tracking tools, and peer review.
- Instrument V&V Theory & Application.
- An understanding of IEC 62304 (Medical Device Software Lifecycle process), ISO 13485, ISO / EN ISO 14971, and FDA QSR experience or equivalent FDA software development requirements.
- Good analytical and problem-solving skills.
- Good organizational skills, and the ability to manage multiple tasks.
- Experience in product development and experimental design.
- Ability to work within cross-functional teams.
- Strong communication skills, written and verbal.
- Must exhibit professionalism, confidence, maturity, desire to succeed, and a self-motivated and proactive orientation.
- Ability to participate in planning and managing projects.
- Working knowledge of product development tools and processes (e.g. Design Input, Design Output, Verification and Validation, Product Risk Management).
- Knowledge of related quality systems regulations and processes.
- Appropriate computer skills (e-mail, word processing, statistical, spreadsheet and graphing software).
- Knowledge of Application life cycle management (Agile method preferred).
- Know and understand the software test cycle.
- Ability to write test plans, test cases and test reports.
Work Environment:
- Temperature: Normal Lab conditions, however, walk in fridge/freezers will be cold.
- Noise level: BL2 lab with a lot of equipment. Can be loud at times.
- Location: Inside.
- Weather: Normal Lab conditions.
- Exposures: BL2 using real patient samples, controls and reagents.
- Workspace: Traditional workspace.
- Other factors: Overtime is expected. Early or late meetings with China Partners.
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